Sarns 800 Roller Pump
FDA 510(k) K953901 · 3M Health Care, Sarns
510(k) numberK953901
Submission
- Device name
- Sarns 800 Roller Pump
- Applicant
- 3M Health Care, Sarns
Ann Arbor, MI, US - Received
- August 18, 1995
- Decision date
- April 19, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.4370
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
Other 510(k)s with product code DWB
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K162843 | Small (4) Roller Pump for the Terumo Advanced Perfusion System 1, Large (6) Roller Pump…DWB · Special | Terumo Cardiovascular Systems Corporation | 11/17/2016SE |
| K131618 | Large (6) Roller Pump for Terumo Advanced Perfusion System 1; Large (6) Roller Pump for…DWB · Traditional | Terumo Cardiovascular Systems Corporation | 09/27/2013SE |
| K112587 | Advanced Perfusion System 1 (APS1) Tube Clamp Assembly, Roller Pump 6 Inch Classic Color,DWB · Traditional | Terumo Cardiovascular Systems Corp. | 12/19/2011SE |
| K973237 | Css-Cardioplegia Safety SystemDWB · Traditional | Medtronic Bio-Medicus, Inc. | 04/27/1998SE |
| K972321 | S3 Mast PumpDWB · Traditional | Stoeckert Instrumente | 02/27/1998SE |
| K971520 | S3 Cyclic RPM ControlDWB · Traditional | Stoeckert Instrumente | 09/10/1997SE |
| K960974 | Cobe Century Perfusion PumpDWB · Traditional | Cobe Cardiovascular, Inc. | 07/14/1997SE |
| K953904 | Sarns 9000 Universal Roller PumpDWB · Traditional | 3M Health Care, Ltd. | 04/19/1996SE |
| K955038 | Stockert S3 Double Head Pump ModuleDWB · Traditional | Stoeckert Instrumente | 02/21/1996SE |
| K890904 | Modified Stockert-Shiley Caps Multi. Roller PumpDWB · Traditional | Shiley, Inc. | 04/12/1989SE |
More from Shiley, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K960916 | Sams 8000 Cardioplegia MonitorDSJ · Traditional | 06/04/1996SE |
| K950739 | 3M Sarns Flow Sensor, Centrifugal Control Module 115, 220 V, 900 Perfusion SystemDWA · Traditional | 11/17/1995SE |
| K941653 | Sarns Turbo Membrane Oxygenator ModificationDTZ · Traditional | 08/24/1994SE |
| K941654 | Sarns Filtered Venous Reservior ModificationDTP · Traditional | 07/26/1994SE |
| K940651 | Sarns Ultrasonic Air SensorKRL · Traditional | 05/24/1994SE |
| K935391 | Sarns Sternal Saw II, Sternal Saw II Blade, Sarns Saw Blades-Non-Sterile Bulk PackGFA · Traditional | 02/24/1994SE |
| K934127 | Sarns Low Jetting Aortic Arch CannulaDWF · Traditional | 02/22/1994SE |
| K935977 | Sarns Air Detection SystemKRL · Traditional | 02/04/1994SE |
| K915547 | Sarns 8000 Delphin II Centri Pump Mod W/Integr BatKFM · Traditional | 09/09/1993SE |
| K925076 | Sarns Turbo Membrane Oxygena. W/Int. Cardiotomy R.DTZ · Traditional | 06/07/1993SE |
Questions and answers
When was Sarns 800 Roller Pump cleared by the FDA?
Sarns 800 Roller Pump (K953901) received a 510(k) decision of Substantially Equivalent on April 19, 1996, 245 days after the submission was received.
What is the product code of K953901?
The FDA product code is DWB – Pump, Blood, Cardiopulmonary Bypass, Roller Type, a Class II (moderate risk) device regulated under 21 CFR 870.4370.